MY ALLERGY TEST


Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K021698
Device Name MY ALLERGY TEST
Original Applicant
IMMUNETECH CORPORATION
p.o. box 9433
17394 via del bravo
rancho santa fe, 
CA 
92067

Original Contact vivianne noetzel
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 05/22/2002
Decision Date 09/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls